Self-monitoring of Blood Glucose in Insulin-treated Patients With Type 2 Diabetes
Self-monitoring of Blood Glucose in Insulin-treated Patients With Type 2 Diabetes: a 9-month Randomised Controlled Trial
Primary Objective:
The objective of the study is to investigate the effect of a specific frequency of Self-monitoring of blood glucose (SMBG) on glycemic control and quality of life in patients with type 2 diabetes and who are in stable good glycemic control and using 1 insulin injection daily.
The research question is:
Does a less intensive frequency of SMBG in insulin-treated patients with type 2 diabetes, who are in stable good glycemic control, using 1 insulin injection daily, lead to a clinically relevant increase of HbA1c (an increase of 0.5%) and what is the effect on quality of life?
Secondary objectives:
The secondary objectives is to investigate the effect of a specific frequency of SMBG on the number of hypo and hyper glycaemia, number of extra diabetes-related contacts with the health care provider, and the diabetes medication.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
SUMMARY
Rationale:
Self-monitoring of blood glucose (SMBG) is an important tool in diabetes care to achieve and maintain good glycemic control. But how often 'should' the patient measure the capillary glucose concentration? There is no general agreement between professionals, and there is no evidence for a specific frequency and timing.
Objective:
The objective of the study is to investigate the effect of a specific frequency of SMBG on glycemic control and quality of life in patients with type 2 diabetes and who are in stable good glycemic control and using 1 insulin injection daily.
Study design:
An open Randomised Controlled Trial.
Study population:
Patients with insulin-treated diabetes type 2, > 18 years of age, using 1 insulin injection daily, performing SMBG > 1 year, HbA1c ≤ 58 mmol/mol (< 7.5%) in the preceding 12 months, sufficient knowledge of the Dutch language, no hypo-unawareness, no serious co-morbidity
Intervention:
Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime) one day weekly in group A, one day per two weeks in group B and one day monthly in group C. Patients are asked to keep a diary with the readings and the probably extra measurements, including the reasons.
Main study parameters/endpoints:
The main study parameters are glycemic control and quality of life. A difference of > 0.5% (> 5.5 mmol/mol) in HbA1c is considered to be relevant. Quality of life is measured with 3 validated questionnaires.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients in this study are used to perform SMBG. During the study, they are asked to monitor their glucose concentrations in a controlled, specific frequency (different kind of usual care are compared). And they are asked to fill in 3 questionnaires in the beginning and at the end of the study. Extra HbA1c measurements can be necessary. No side effects are expected, but safety is incorporated through HbA1c measurements every 3 months and every 3 months the diary will be discussed in the scheduled visits. Furthermore, extra measurements are allowed when necessary.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Zwolle, Olanda, 8025 BT
- Reclutamento
- Diabetes centre, isala clinics
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Investigatore principale:
- Henk JG Bilo, MD PhD FCRP
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients with insulin-treated diabetes type 2
- > 18 years of age
- using 1 insulin injection daily,
- performing SMBG > 1 year
- HbA1c ≤ 58 mmol/mol (< 7.5%) in the preceding 12 months
- sufficient knowledge of the Dutch language.-
Exclusion Criteria:
- no hypo-unawareness
- no serious co-morbidity (as judged by their own GP)
- patients who measure their blood glucose concentration (4 measurements a day) more than once a week on average
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: high frequency of SMBG
Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime) one day weekly in group A.
|
Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime: high frequency: one day weekly middle frequency:one day per two weeks low frequency:one day monthly |
|
Sperimentale: middle frequency of SMBG
Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime) one day per two weeks in group B.
|
Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime: high frequency: one day weekly middle frequency:one day per two weeks low frequency:one day monthly |
|
Sperimentale: low frequency of SMBG
Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime) Group C: one day monthly
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Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime: high frequency: one day weekly middle frequency:one day per two weeks low frequency:one day monthly |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
HbA1c
Lasso di tempo: 9 months
|
The main study parameter is glycemic control.
Glycemic control is measured by HbA1c.
A difference of 0.5% (> 5.5 mmol/mol) in HbA1c between groups is considered to be relevant.
|
9 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
quality of life
Lasso di tempo: 9 months
|
The secondary study parameter is quality of life.
The quality of life is measured by 3 validated questionnaires: the 12-item Short Form Health Survey, the 20-item Problems Areas in Diabetes Scale (PAID) and the 13-item Summary of Diabetes Self care Activities.
Furthermore, the glucose concentrations measured by SMBG should be between 4-7 mmol/l, preprandial and between 8-10 mmol/l before bed time.
The endpoint is the number of glucose concentrations who are out of range at every 4th week.The number of hypo and hyperglycaemia are reported in the diary.
|
9 months
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Henk JG Bilo, MD PhD FCRP, Isala
Pubblicazioni e link utili
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Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 35308.075.11
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